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Drug firm withdraws statin from the market
POLICY AND PEOPLE
Bush supports limited funding for stem-cell research and disorders that affect 100 million Americans”.
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
AP
tating that embryonic stem-cells carry both “great promise and great peril”, US President George W Bush announced on Aug 9 his support for limited federal funding for embryonic stem-cell research. The decision allows research on existing stem-cell lines only. Bush said some 60 stemcell lines, created with private money, already exist. He also said “aggressive federal funding” would continue for research on other types of stem cells: umbilical cord, placental, adult, and animal. And he announced the creation of a Presidential Council, chaired by University of Chicago bioethicist and physician Leon Kass, that will consider the moral and ethical questions raised by stem-cell research and related technologies. Reaction to the decision was mixed. Representatives of some disease groups, including actor Christopher Reeve, now a quadriplegic as the result of a riding accident, were disappointed. In a written statement, Reeve called the decision a “political compromise [that] may seriously hinder progress toward finding treatments and cures for a wide variety of diseases
S
Leon Kass
Among supporters of the decision was the US Senate’s only physician member, transplant surgeon Bill Frist, who praised Bush for allowing research to proceed “while maintaining strong restrictions on the extent of the research and ensuring comprehensive, public oversight”. Some conservatives and antiabortion groups, fearing the prospect of a more liberal policy, were relieved at the restrictions, but others were dismayed at the lack of an outright ban.
Drug firm withdraws statin from the market n Aug 8, German drug company Bayer AG announced the withdrawal of its cholesterol-lowering drug cerivastatin after it was linked to the deaths of 52 patients in the USA and Europe. Cerivastatin, on the market since 1997 as Baycol in the USA and as Lipobay in Europe, is a statin, which meant that it lowers serum-cholesterol by blocking the enzyme HMG-CoAreductase. Since their introduction in 1987 statins have been associated with rare reports of rhabdomyolysis. The muscle tissue breakdown in this condition is usually reversible, but can be fatal when renal insufficiency and other organ failure develops. “We decided to withdraw the drug when it became clear that cases of fatal rhabdomyolysis were reported more often in association with the use of cerivastatin than for the other statins”, says Michael Diehl, spokesman for Bayer, Leverkusen, Germany, “These fatal cases were seen most often when the drug was used at higher doses, in elderly patients, and in combination with gemfibrozil. Of the 31 US patients who died, 12 also took gemfibrozil”. Gemfibrozil is a lipid-lowering drug of the fibrate class. It is sometimes added
O
568
when a patient’s cholesterol does not respond satisfactorily to statin monotherapy. “Therefore the product is not withdrawn in Japan, as gemfibrozil and the high dose 0·8 mg cerivastatin are not marketed there”, adds Diehl. The withdrawal has raised concerns about the safety of the other statins. A consumer advocacy group has asked the US Food and Drug Administration (FDA) to improve warning labels on all statins. The FDA has said that the millions of patients taking statins should not panic. Maarten Simoons, University Hospital Rotterdam, The Netherlands, agrees “Rhabdomyolysis is a very rare sideeffect which does not outweigh the clinically proven substantial benefits that statins offer. Cerivastatin has never been studied in a clinical trial with large numbers of patients, so perhaps that was the reason this drug’s more frequent side-effect was not picked up.” The European Medicines Evaluation Agency in London, UK, however, has announced that it will conduct a safety review of other statins in the next few months. Wim Weber
Sam Casey, chief counsel at Human Life Advocates, a public interest law firm, told The Lancet that the President “proposed something that is currently illegal, under Congress’s existing federal-funding ban, and it should stay illegal”. US Secretary of Health and Human Services Tommy Thompson said in a television interview that informed consent is one of four conditions that must be met if a stem-cell line, which must have been in existence on Aug 9, is to be used. The other three conditions are: the cells must have been created from excess embryos produced in an in-vitro fertilisation laboratory; the cells must not have been produced for the purposes of research; and donors must not have been given a financial incentive. He said that the National Institutes of Health would be setting up a registry of the existing stem-cell lines, which come from around the world. However, some scientists have expressed scepticism about the number of existing cell lines, their quality, robustness, and accessibility. Faith McLellan
US FDA improves warning on abused drug
I
n light of increasing evidence of abuse of OxyContin (controlledrelease oxycodone HCI), the US FDA strengthened the drug’s warning label on July 25. The manufacturer, Purdue Pharma (Stamford, CT, USA), worked with the FDA to develop the changes in the prescribing information, provided in the form of a “Dear Healthcare Professional” letter and in the drug’s labelling as a “black-box warning”, the strongest type of warning label. As a pure opioid agonist analgesic, OxyContin, which is indicated for the management of moderate to severe chronic pain, has a similar potential for addiction as morphine. Abusers have learnt that crushing the tablet causes rapid release of the active ingredient and produces a powerful high. On Aug 8, Purdue Pharma announced that an “abuse-resistant” form of the drug was in development.
Faith McLellan
THE LANCET • Vol 358 • August 18, 2001
For personal use. Only reproduce with permission from The Lancet Publishing Group.
Bush supports limited funding for stem-cell research and disorders that affect 100 million Americans”.
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
AP
tating that embryonic stem-cells carry both “great promise and great peril”, US President George W Bush announced on Aug 9 his support for limited federal funding for embryonic stem-cell research. The decision allows research on existing stem-cell lines only. Bush said some 60 stemcell lines, created with private money, already exist. He also said “aggressive federal funding” would continue for research on other types of stem cells: umbilical cord, placental, adult, and animal. And he announced the creation of a Presidential Council, chaired by University of Chicago bioethicist and physician Leon Kass, that will consider the moral and ethical questions raised by stem-cell research and related technologies. Reaction to the decision was mixed. Representatives of some disease groups, including actor Christopher Reeve, now a quadriplegic as the result of a riding accident, were disappointed. In a written statement, Reeve called the decision a “political compromise [that] may seriously hinder progress toward finding treatments and cures for a wide variety of diseases
S
Leon Kass
Among supporters of the decision was the US Senate’s only physician member, transplant surgeon Bill Frist, who praised Bush for allowing research to proceed “while maintaining strong restrictions on the extent of the research and ensuring comprehensive, public oversight”. Some conservatives and antiabortion groups, fearing the prospect of a more liberal policy, were relieved at the restrictions, but others were dismayed at the lack of an outright ban.
Drug firm withdraws statin from the market n Aug 8, German drug company Bayer AG announced the withdrawal of its cholesterol-lowering drug cerivastatin after it was linked to the deaths of 52 patients in the USA and Europe. Cerivastatin, on the market since 1997 as Baycol in the USA and as Lipobay in Europe, is a statin, which meant that it lowers serum-cholesterol by blocking the enzyme HMG-CoAreductase. Since their introduction in 1987 statins have been associated with rare reports of rhabdomyolysis. The muscle tissue breakdown in this condition is usually reversible, but can be fatal when renal insufficiency and other organ failure develops. “We decided to withdraw the drug when it became clear that cases of fatal rhabdomyolysis were reported more often in association with the use of cerivastatin than for the other statins”, says Michael Diehl, spokesman for Bayer, Leverkusen, Germany, “These fatal cases were seen most often when the drug was used at higher doses, in elderly patients, and in combination with gemfibrozil. Of the 31 US patients who died, 12 also took gemfibrozil”. Gemfibrozil is a lipid-lowering drug of the fibrate class. It is sometimes added
O
568
when a patient’s cholesterol does not respond satisfactorily to statin monotherapy. “Therefore the product is not withdrawn in Japan, as gemfibrozil and the high dose 0·8 mg cerivastatin are not marketed there”, adds Diehl. The withdrawal has raised concerns about the safety of the other statins. A consumer advocacy group has asked the US Food and Drug Administration (FDA) to improve warning labels on all statins. The FDA has said that the millions of patients taking statins should not panic. Maarten Simoons, University Hospital Rotterdam, The Netherlands, agrees “Rhabdomyolysis is a very rare sideeffect which does not outweigh the clinically proven substantial benefits that statins offer. Cerivastatin has never been studied in a clinical trial with large numbers of patients, so perhaps that was the reason this drug’s more frequent side-effect was not picked up.” The European Medicines Evaluation Agency in London, UK, however, has announced that it will conduct a safety review of other statins in the next few months. Wim Weber
Sam Casey, chief counsel at Human Life Advocates, a public interest law firm, told The Lancet that the President “proposed something that is currently illegal, under Congress’s existing federal-funding ban, and it should stay illegal”. US Secretary of Health and Human Services Tommy Thompson said in a television interview that informed consent is one of four conditions that must be met if a stem-cell line, which must have been in existence on Aug 9, is to be used. The other three conditions are: the cells must have been created from excess embryos produced in an in-vitro fertilisation laboratory; the cells must not have been produced for the purposes of research; and donors must not have been given a financial incentive. He said that the National Institutes of Health would be setting up a registry of the existing stem-cell lines, which come from around the world. However, some scientists have expressed scepticism about the number of existing cell lines, their quality, robustness, and accessibility. Faith McLellan
US FDA improves warning on abused drug
I
n light of increasing evidence of abuse of OxyContin (controlledrelease oxycodone HCI), the US FDA strengthened the drug’s warning label on July 25. The manufacturer, Purdue Pharma (Stamford, CT, USA), worked with the FDA to develop the changes in the prescribing information, provided in the form of a “Dear Healthcare Professional” letter and in the drug’s labelling as a “black-box warning”, the strongest type of warning label. As a pure opioid agonist analgesic, OxyContin, which is indicated for the management of moderate to severe chronic pain, has a similar potential for addiction as morphine. Abusers have learnt that crushing the tablet causes rapid release of the active ingredient and produces a powerful high. On Aug 8, Purdue Pharma announced that an “abuse-resistant” form of the drug was in development.
Faith McLellan
THE LANCET • Vol 358 • August 18, 2001
For personal use. Only reproduce with permission from The Lancet Publishing Group.